U.S. patent application number 14/621021 was filed with the patent office on 2015-06-04 for systems for inactivating fluid cultures through heating.
The applicant listed for this patent is LIFE TECHNOLOGIES CORPORATION. Invention is credited to Jacob D. Lee, Whitt F. Woods.
Application Number | 20150151262 14/621021 |
Document ID | / |
Family ID | 46455394 |
Filed Date | 2015-06-04 |
United States Patent
Application |
20150151262 |
Kind Code |
A1 |
Lee; Jacob D. ; et
al. |
June 4, 2015 |
SYSTEMS FOR INACTIVATING FLUID CULTURES THROUGH HEATING
Abstract
A fluid heating system includes a tank assembly having an
interior surface bounding a chamber, the tank assembly having: a
sidewall encircling the chamber and extending between a first end
and an opposing second end, the first end bounding an opening to
the chamber; and a lid movable between a first position wherein the
opening to the chamber is exposed and a second position wherein the
lid is disposed over the opening. A collapsible bag is removably
disposed within the chamber of the tank assembly, the collapsible
bag bounding a compartment adapted to hold a fluid. Systems are
provided for controlling the temperature of fluid within the
collapsible bag when the collapsible bag is positioned within
chamber of the tank assembly. A mixing element is disposed within
the compartment of the collapsible bag.
Inventors: |
Lee; Jacob D.; (Smithfield,
UT) ; Woods; Whitt F.; (North Ogden, UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LIFE TECHNOLOGIES CORPORATION |
Carlsbad |
CA |
US |
|
|
Family ID: |
46455394 |
Appl. No.: |
14/621021 |
Filed: |
February 12, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14075933 |
Nov 8, 2013 |
8961875 |
|
|
14621021 |
|
|
|
|
12986734 |
Jan 7, 2011 |
8608369 |
|
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14075933 |
|
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Current U.S.
Class: |
366/145 |
Current CPC
Class: |
B01F 15/00006 20130101;
C12M 41/24 20130101; C12M 23/14 20130101; C12M 23/48 20130101; A61L
2/0023 20130101; B01F 7/00691 20130101; B01F 7/00341 20130101; C12M
47/20 20130101; C12M 37/00 20130101; B01F 15/0072 20130101; B01F
7/00375 20130101; F24H 1/122 20130101; B01F 15/00396 20130101; B01F
2215/0032 20130101; C12M 23/38 20130101; B01F 7/00725 20130101;
B01F 15/00785 20130101; B01F 7/1695 20130101; C12M 23/26 20130101;
B01F 15/063 20130101; B01F 15/0085 20130101; B01F 2015/062
20130101 |
International
Class: |
B01F 15/00 20060101
B01F015/00; B01F 7/00 20060101 B01F007/00 |
Claims
1. A fluid heating system comprising: a tank assembly having an
interior surface bounding a chamber, the tank assembly comprising:
a sidewall encircling the chamber and extending between a first end
and an opposing second end, the first end bounding an opening to
the chamber; and a lid movable between a first position wherein the
opening to the chamber is exposed and a second position wherein the
lid is disposed over the opening; a collapsible bag removably
disposed within the chamber of the tank assembly, the collapsible
bag bounding a compartment adapted to hold a fluid; means for
controlling the temperature of fluid within the collapsible bag
when the collapsible bag is positioned within chamber of the tank
assembly; and a mixing element disposed within the compartment of
the collapsible bag.
2. The fluid heating system as recited in claim 1, further
comprising a driver communicating with the mixing element, the
drive being adapted to move the mixing element when the lid is in
the second position.
3. The fluid heating system as recited in claim 2, the drive being
adapted to move the mixing element when the lid is in the first
position and the second position.
4. The fluid heating system as recited in claim 2, wherein the
mixing element comprises an impeller and is rotated by the
driver.
5. The fluid heating system as recited in claim 2, further
comprising: an elongated drive shaft removably coupled with the
mixing element such that rotation of the drive shaft facilitates
rotation of the mixing element within the compartment of the
collapsible bag; and the driver comprising a drive motor assembly
coupled with the drive shaft, the drive motor assembly being
adapted to rotate the drive shaft when the lid is in the second
position.
6. The fluid heating system as recited in claim 1, wherein the tank
assembly further comprises a floor disposed at the second end of
the sidewall.
7. The fluid heating system as recited in claim 1, further
comprising an opening extending through the tank assembly, the
drive being at least partially disposed within the opening so as to
communicate with the chamber of the tank assembly.
8. The fluid heating system as recited in claim 1, further
comprising a rotational assembly mounted to the collapsible bag,
the rotational assembly comprising: a casing secured to the
collapsible bag; a hub rotatably mounted to the casing, the hub
having a passageway extending therethrough; and an elongated
tubular connector having a first end and an opposing second end,
the first end of the connector being connected to the hub and the
second end of the connector being secured to the mixing
element.
9. The fluid heating system as recited in claim 1, wherein the
means for controlling the temperature of the fluid comprise a fluid
channel disposed within the sidewall of the tank assembly.
10. The fluid heating system as recited in claim 1, wherein the
means for controlling the temperature of the fluid comprise a fluid
channel disposed within the lid of the tank assembly.
11. The fluid heating system as recited in claim 9, further
comprising: a boiler for heating fluid; and a pump for pumping the
heated fluid from the boiler through the fluid channel within the
sidewall of the tank assembly.
12. The fluid heating system as recited in claim 1, further
comprising: a temperature port assembly coupled to the collapsible
bag, the temperature port assembly bounding a cavity that projects
into the compartment of the collapsible bag but is not in fluid
communication with the compartment; and a temperature probe
positioned with the cavity of the temperature port assembly.
13. The fluid heating system as recited in claim 12, further
comprising a support extending between the tank assembly and the
temperature port assembly, the support supporting the temperature
port assembly within the chamber of the tank assembly at a distance
from the sidewall.
14. A fluid heating system comprising: a tank assembly having an
interior surface bounding a chamber, the tank assembly comprising
an opening communicating with chamber and a cover that removably
covers the opening. a collapsible bag disposed within the chamber
of the tank assembly so that the tank assembly substantially
encloses collapsible bag, the collapsible bag bounding a
compartment adapted to hold a fluid; means for controlling the
temperature of fluid within the collapsible bag when the
collapsible bag is positioned within chamber of the tank assembly;
and means for mixing fluid within the collapsible bag when the
collapsible bag is disposed within the chamber of the tank
assembly.
15. The fluid heating system as recited in claim 14, wherein the
means for controlling the temperature of the fluid comprises: a
fluid channel disposed within the tank assembly; a boiler for
heating fluid; and a pump for pumping the heated fluid from the
boiler through the fluid channel within the tank assembly.
16. The fluid heating system as recited in claim 14, further
comprising: a temperature port assembly coupled to the collapsible
bag, the temperature port assembly bounding a cavity that projects
into the compartment of the collapsible bag but is not in fluid
communication with the compartment; and a temperature probe
positioned with the cavity of the temperature port assembly.
17. The fluid heating system as recited in claim 16, wherein the
temperature port assembly comprises: a port secured to the flexible
bag; and a probe adapter secured to the port, the probe adapter
comprising: a tubular sleeve received over the port; a mounting
flange radially outwardly projecting from the sleeve; and a
receiver coupled to the sleeve and projecting down through the
sleeve, the receiver bounding the cavity of the temperature port
assembly.
18. The fluid heating system as recited in claim 16, further
comprising a support extending between the tank assembly and the
temperature port assembly, the support supporting the temperature
port assembly within the chamber of the tank assembly at a distance
from the sidewall.
19. The fluid heating system as recited in claim 18, wherein the
support comprises: a flange mounted to the sidewall of the tank
assembly and projecting into the chamber; and a retainer disposed
at an end of the flange, the probe adapter being supported on the
retainer.
20. The fluid heating system as recited in claim 19, further
comprising a clamp removably securing the probe adapter to the
retainer.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 14/075,933, filed Nov. 8, 2013, which is a divisional of U.S.
application Ser. No. 12/986,734, filed Jan. 7, 2011, U.S. Pat. No.
8,608,369, which are incorporated herein by specific reference in
its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. The Field of the Invention
[0003] The present invention relates to systems for heating and
mixing fluids which can be used for inactivating cells or
microorganisms.
[0004] 2. The Relevant Technology
[0005] The biopharmaceutical industry uses a broad range of mixing
systems for a variety of processes such as in the preparation of
media and buffers and in the growing or processing of cells and
microorganisms. Many conventional mixing systems, including
bioreactors, comprise a rigid tank that can be sealed closed. A
drive shaft with impeller is rotatably disposed within the tank.
The impeller functions to suspend and mix the components.
[0006] In many cases, great care must be taken to sterilize and
maintain the sterility of the mixing system so that the culture or
other product does not become contaminated. Accordingly, between
the production of different batches, the mixing tank, mixer, and
all other reusable components that contact the processed material
must be carefully cleaned to avoid any cross contamination. The
cleaning of the structural components is labor intensive, time
consuming, and costly. For example, the cleaning can require the
use of chemical cleaners such as sodium hydroxide and may require
steam sterilization as well. The use of chemical cleaners has the
additional challenge of being relatively dangerous, and cleaning
agents can be difficult and/or expensive to dispose of once
used.
[0007] Once processing step commonly used with biological fluids
containing a culture is to heat the fluid to a defined temperature
to kill or inactivate the cells or microorganisms therein. This has
historically been accomplished by heating the fluid within a
stainless steel tank. Such processing, however, again requires the
cleaning and sterilization of the tank between different
batches.
[0008] Accordingly, what is needed in the art are system that
permit controlled and uniform heating of a fluid that does not
require washing or sterilization between batches and that minimizes
any potential for breach in sterility.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Various embodiments of the present invention will now be
discussed with reference to the appended drawings. It is
appreciated that these drawings depict only typical embodiments of
the invention and are therefore not to be considered limiting of
its scope.
[0010] FIG. 1 is perspective view of a fluid heating system
incorporating features of the present invention;
[0011] FIG. 2 is a cross sectional side view of the tank assembly
of the fluid heating system shown in FIG. 1;
[0012] FIG. 3 is a bottom perspective view of the tank assembly
shown in FIG. 2;
[0013] FIG. 4 is a perspective view of the tank assembly shown in
FIG. 1 with the lid in a closed position;
[0014] FIG. 5 is a cross sectional side view of the fluid heating
system shown in FIG. 1;
[0015] FIG. 6 is a front side plan view of the container assembly
shown in FIG. 1 in a collapsed position;
[0016] FIG. 7 is a back side plan view of a container assembly
shown in FIG. 6 in a collapsed position;
[0017] FIG. 8 is an exploded perspective view of a temperature port
assembly of the container assembly shown in FIG. 6 with related
parts;
[0018] FIG. 9 is a cross sectional side view of the temperature
port assembly shown in FIG. 8;
[0019] FIG. 10 is an elevated side view of an impeller assembly and
drive shaft used in the fluid heating system;
[0020] FIG. 11 is a partially disassembled perspective view of the
impeller assembly, drive shaft and drive motor assembly of the
fluid heating system;
[0021] FIG. 12 is an enlarged view of the rotational assembly and
drive motor W8 assembly in a disassembled view state; and
[0022] FIG. 13 is an elevated front view of the rotational assembly
and drive motor assembly coupled together.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0023] The present invention relates to systems and methods for
heating fluids but can also be used for mixing and/or cooling
fluids. The systems can commonly be used for inactivating cells or
microorganism in a biological fluid by heating the fluid. For
example, the systems can be used for inactivating yeast cells by
heating media containing the cells to a defined temperature and
then holding the media at the temperature for a defined time. The
systems can be used with other cells or microorganism and can be
used for heating and/or mixing other biological or non-biological
fluids for other purposes such as sterilization or fluid
processing.
[0024] The inventive systems are designed so that a majority of the
system components that contact the material being processed can be
disposed of after each use. As a result, the inventive systems
substantially eliminate the burden of cleaning and sterilization
required by conventional stainless steel mixing systems. This
feature also ensures that sterility can be consistently maintained
during repeated processing of multiple batches. In view of the
foregoing, and the fact that the inventive systems are easily
scalable, relatively low cost, and easily operated, the inventive
systems can be used in a variety of industrial and research
facilities that previously outsourced such processing.
[0025] Depicted in FIG. 1 is one embodiment of an inventive fluid
heating system 10 incorporating features of the present invention.
In general, fluid heating system 10 comprises a tank assembly 12, a
container assembly 16 that is disposed within and supported by tank
assembly 12, and a drive shaft 18 (FIG. 2) that extends between
tank assembly 12 and container assembly 16. Container assembly 16
houses the fluid or solution that is heated and can also be mixed
and/or cooled. The various components of fluid heating system 10
will now be discussed in greater detail.
[0026] Continuing with FIG. 1, tank assembly 12 comprises a tank
body 102 having a lid 104 hingedly coupled thereto. Tank body 102
comprises a substantially cylindrical sidewall 106 having an
interior surface 108 that extends between an upper end 110 and an
opposing lower end 112. As depicted in FIG. 2, tank body 102 also
includes a floor 114 located at lower end 112 with a drain opening
116 extending therethrough. Interior surface 108 of sidewall 106
and floor 114 bound a chamber 118. As discussed below, chamber 118
is configured to receive container assembly 16 so that container
assembly 16 is supported therein. A substantially C-shaped lip 120
is formed at upper end 110 of sidewall 106 and partially bounds an
access opening 122 to chamber 118. A pair of spaced apart slots
124A and B are recessed on lip 120 and, as will be discussed below
in greater detail, provide channels through which fluid lines can
pass out of chamber 118 when lid 104 is closed.
[0027] In general, tank body 102 has a front face 126 and an
opposing back face 128. As best shown in FIG. 1, an enlarged notch
130 is formed on front face 126 at upper end 110 and extends
through sidewall 106 and lip 120. Disposed within notch 130 so as
to communicate with chamber 118 is a drive motor assembly 132. As
will be discussed below in greater detail, drive motor assembly 132
is used to rotate drive shaft 18 (FIG. 2) which in turn mixes the
fluid within container assembly 16. Although not required, drive
motor assembly 132 is typically fitted so that notch 130 is sealed
closed. A generally U-shaped flange 134 having a top surface 136
extends between opposing sides of notch 130 along an inside face of
drive motor assembly 132. Top surface 136 at opposing ends of
flange 134 is flush with lip 120 so that lip 120 and flange 134
combine to form sealing surface 137 that bounds access opening 122
of chamber 118.
[0028] As shown in FIG. 3, formed on back face 128 of tank body 102
is a hinge 138 that connects lid 104 to tank body 102. Hinge 138
enables lid 104 to be manually moved between an open position as
shown in FIG. 1 and a closed position as shown in FIG. 4. A handle
142, shown in this embodiment as having a U-shaped configuration,
is formed on lid 104 to assist in movement of lid 104 between the
two positions. Continuing with FIG. 3, a piston 140 has a first end
hingedly coupled with a lid portion 141 of hinge 138 and an
opposing second end hingedly coupled with tank body 102. Piston 140
assists in smooth and controlled movement of lid 104 so that lid
104 does not unintentionally slam shut. Lid 104 has a notch 144
formed on a front face thereof opposite hinge 138. Notch 144 is
sized to receive drive motor assembly 132 when lid 104 is in the
closed position (FIG. 4). Returning to FIG. 1, lid 104 has an
inside face 148 having a gasket 150 extending along a perimeter
edge thereof. When lid 104 is in the closed position, gasket 150
sites on top of sealing surface 138 so that drain opening 116 to
chamber 118 is substantially sealed closed. It is noted that when
lid 104 is closed, slots 124A and B (FIG. 2) will still be open to
chamber 118 which can be a source of heat loss. Such heat loss,
however, is negligible. If desired, inserts can be placed within
slots 124A and B to seal them off when not in use. In some
embodiments, slots 124A and B can be eliminated.
[0029] As shown in FIG. 4, tank assembly 12 also includes a locking
assembly 152 that helps to ensure a tight and secure sealed
engagement between lid 104 and tank body 102. In the embodiment
depicted, locking assembly 152 includes a catch 154 formed on and
radially outwardly projecting out from lid 104. Catch 154 has a
slot 155 (FIG. 1) formed on an end face thereof. In turn, a
fastener 156 is mounted on tank body 102 below catch 154. Fastener
156 includes a threaded bolt 158 having a first end hingedly
mounted to tank body 102 and an opposing second end having a handle
160 threaded thereon. When lid 104 is in the closed position,
fastener 156 is rotated so that bolt 158 is received within slot
155 of catch 154. Handle 160 can then be selectively rotated to
advance along bolt 158. In so doing, handle 160 biases against
catch 154 and clamps lid 104 to tank body 102. If desired, two or
more locking assemblies 152 can be used. In alternative
embodiments, it is appreciated that the depicted locking assembly
152 can be replaced with any number of conventional locking systems
such as latches, clamps, fasteners, screws, elastic cords, or any
other structure that can temporarily secure lid 104 to tank body
102. In yet other embodiments, locking assembly 152 can be
eliminated.
[0030] Although tank body 102 is shown as having a substantially
cylindrical configuration, in alternative embodiments tank body 102
can have any desired shape capable of at least partially bounding a
chamber. For example, sidewall 106 need not be cylindrical but can
have a variety of other transverse, cross sectional configurations
such as polygonal, elliptical, or irregular. Furthermore, it is
appreciated that tank body 102 can be scaled to any desired size.
For example, it is envisioned that chamber 118 of tank body 102 can
be sized to hold a maximum volume of fluid in a range between about
50 liters to about 2,500 liters with about 75 liters to about 1,000
liters being common and about 75 liters to about 300 liters being
more common. Other sizes can also be used. Tank body 102 and lid
104 are typically made of metal, such as stainless steel, but can
also be made of other materials capable of withstanding the applied
loads and temperatures of the present invention.
[0031] In one embodiment of the present invention means are
provided for controlling the temperature of the fluid that is
contained within container assembly 16 when container assembly 16
is disposed within chamber 118 of tank assembly 12. By way of
example and not by limitation, tank body 102 and lid 104 can both
be jacketed so as to bound one or more fluid channels through which
heated or cooled fluid can pass. In turn, heat from the heated
fluid flowing through tank assembly 12 radiates to the fluid within
container assembly 16 for heating the fluid therein. Alternatively,
chilled fluid flowing through tank assembly 12 draws heat from the
fluid within container assembly 16 for cooling the fluid therein.
For example, as shown in FIG. 2, sidewall 106 comprises an inside
wall 162 and an outside wall 164 that bound a fluid channel 166
therebetween; floor 114 comprises an inside wall 168 and an outside
wall 170 that bound a fluid channel 172 therebetween; and lid 104
comprises an inside wall 174 and an outside wall 176 that bound a
fluid channel 178 therebetween. If desired an insulation layer 179
can be positioned between each outside wall 164, 170, and 176 and
the corresponding fluid channel.
[0032] Turning to FIG. 3, outside wall 176 of lid 104 has an inlet
port 180 and an outlet port 182 formed thereon and communicating
with fluid channel 178 (FIG. 2). A hose coupling 181 is coupled
with inlet port 180. Hose coupling 181 is designed to couple with a
fluid line that extends from a thermal control unit (TCU) 197 or
some other source for generating or providing a heated or cooled
fluid so that the fluid can be pumped into fluid channel 178 at a
desired temperature and flow rate. The fluid can be water,
propylene glycol, or other types of fluids commonly used in this
type of heating or cooling. In one embodiment, the TCU 197 can
comprise a boiler 198 fluid coupled with a pump 199 which delivers
the fluid to house coupling 181. A chiller and other components can
also be used.
[0033] Outside wall 162 of sidewall 106 has an inlet port 184 and
an outlet port 186 formed thereon and communicating with fluid
channel 166 (FIG. 2). A fluid line 188 extends from outlet port 182
on lid 104 to inlet port 184 of sidewall 106 so that after the
heated fluid passes through fluid channel 178 in lid 104 it can
then pass through fluid channel 166 in sidewall 162. In turn,
outside wall 170 of floor 114 has an inlet port 190 and an outlet
port 192 formed thereon and communicating with fluid channel 172
(FIG. 2). A fluid line 194 extends from outlet port 186 on sidewall
106 to inlet port 190 of floor 114 so that after the heated fluid
passes through fluid channel 166 in sidewall 162 it can then pass
through fluid channel 172 in floor 114.
[0034] Finally, a hose coupling 196 is coupled with outlet port 192
of floor 114 so that a fluid line can be coupled therewith and
extend back to TCU 197 where the fluid is then heated or cooled
back to the desired temperature before repeating the cycle. The
fluid flow system can thus be a close loop, recirculating system.
It is appreciated that partitions or other structures can be formed
within fluid channels 166, 172, and 178 to optimize fluid flow
throughout so that tank body 102 and lid 104 apply a substantially
uniform and continuous heat or cooling around all sides of
container assembly 16 when container assembly 16 is disposed within
tank assembly 12.
[0035] In alternative embodiments, it is appreciated that the
heated or cooled fluid can enter through hose coupling 190 on floor
114 and then exit out through hose coupling 181 on lid 104. In
still other embodiments, separate recirculating systems can be
coupled with each of lid 104, sidewall 106 and/or floor 114. In
contrast to using a heated liquid fluid, heated gas or steam can be
used. Alternatively, the means for controlling the temperature can
comprise electrical heating elements placed on the exterior
surfaces of inside walls 162, 168, and 174. Other conventional
heating or cooling systems can also be used. The means for
controlling the temperature can be used to heat the fluid within
container assembly 16 to a temperature in a range between about
30.degree. C. to about 130.degree. C. with about 50.degree. C. to
about 70.degree. C. being more common. Other temperatures can also
be used.
[0036] As also shown in FIG. 2, tank assembly 12 also includes a
support 200 secured to interior surface 108 of sidewall 106 at
upper end 110. Support 200 includes a flange 202 attached to and
projecting from sidewall 106 and a substantially C-shaped retainer
204 disposed at the end thereof. Retainer 204 includes a stem 206
and a flange 208 radially outwardly projecting therefrom, both stem
206 and a flange 208 having a substantially C-shaped configuration.
As will be discussed below in greater detail, support 200 is used
for supporting a portion of container assembly 16 and for
supporting a temperature probe 210 therein.
[0037] As shown in FIG. 1, tank assembly 12 is typically mounted on
a platform 212. If desired, one or more load cells can be
incorporated into platform 212 so that the quantity of fluid
delivered to container assembly 12 when disposed within tank
assembly 12 can be accurately measured. FIG. 1 also shows an
electrical controller 214. Controller 214 can be used for measuring
and controlling operational parameters such as the heat and flow
rate of fluid through the fluid channels, as discussed above,
tracking the time and temperature that the fluid within container
assembly 12 is heated, measuring the weight of fluid entering
container assembly 12 and controlling mixing of the fluid within
container assembly 12 as will be discussed below in greater
detail.
[0038] Turning to FIG. 5, container assembly 16 comprises a
container 18 having a side 20 that extends from an upper end 22 to
an opposing lower end 24. Upper end 22 terminates at a top 23 while
lower end 24 terminates at a bottom 25. Container 18 also has an
interior surface 26 that bounds a compartment 28. Compartment 28 is
configured to hold a fluid. In the embodiment depicted, container
18 comprises a flexible bag that is comprised of a flexible, water
impermeable material such as a low-density polyethylene or other
polymeric sheets having a thickness in a range between about 0.1 mm
to about 5 mm with about 0.2 mm to about 2 mm being more common.
Other thicknesses can also be used. The material can be comprised
of a single ply material or can comprise two or more layers which
are either sealed together or separated to form a double wall
container. Where the layers are sealed together, the material can
comprise a laminated or extruded material. The laminated material
comprises two or more separately formed layers that are
subsequently secured together by an adhesive.
[0039] The extruded material comprises a single integral sheet that
comprises two or more layers of different materials that can be
separated by a contact layer. All of the layers are simultaneously
co-extruded. One example of an extruded material that can be used
in the present invention is the Thermo Scientific CX3-9 film
available from Life Technologies Corporation. The Thermo Scientific
CX3-9 film is a three-layer, 9 mil cast film produced in a cGMP
facility. The outer layer is a polyester elastomer coextruded with
an ultra-low density polyethylene product contact layer. Another
example of an extruded material that can be used in the present
invention is the Thermo Scientific CX5-14 cast film also available
from Life Technologies Corporation. The Thermo Scientific CX5-14
cast film comprises a polyester elastomer outer layer, an ultra-low
density polyethylene contact layer, and an EVOH barrier layer
disposed therebetween. In still another example, a multi-web film
produced from three independent webs of blown film can be used. The
two inner webs are each a 4 mil monolayer polyethylene film (which
is referred to by Life Technologies Corporation as the Thermo
Scientific BM1 film) while the outer barrier web is a 5.5 mil thick
6-layer coextrusion film (which is referred to by Life Technologies
Corporation as the Thermo Scientific BX6 film).
[0040] The material is approved for direct contact with living
cells and is capable of maintaining a solution sterile. In such an
embodiment, the material can also be sterilizable such as by
ionizing radiation. Examples of materials that can be used in
different situations are disclosed in U.S. Pat. No. 6,083,587 which
issued on Jul. 4, 2000 and United States Patent Publication No. US
2003/0077466 A1, published Apr. 24, 2003 which are hereby
incorporated by specific reference.
[0041] In one embodiment, container 18 comprise a two-dimensional
pillow style bag wherein two sheets of material are placed in
overlapping relation and the two sheets are bonded together at
their peripheries to form the internal compartment. Alternatively,
a single sheet of material can be folded over and seamed around the
periphery to form the internal compartment. In another embodiment,
container 18 can be formed from a continuous tubular extrusion of
polymeric material that is cut to length and is seamed closed at
the ends.
[0042] In still other embodiments, container 18 can comprise a
three-dimensional bag that not only has an annular side wall but
also a two dimensional top end wall and a two dimensional bottom
end wall. Three dimensional containers comprise a plurality of
discrete panels, typically three or more, and more commonly four or
six. Each panel is substantially identical and comprises a portion
of the side wall, top end wall, and bottom end wall of the
container. Corresponding perimeter edges of each panel are seamed.
The seams are typically formed using methods known in the art such
as heat energies, RF energies, sonics, or other sealing
energies.
[0043] In alternative embodiments, the panels can be formed in a
variety of different patterns. Further disclosure with regard to
one method of manufacturing three-dimensional bags is disclosed in
United States Patent Publication No. US 2002/0131654 A1 that was
published Sep. 19, 2002 of which the drawings and Detailed
Description are hereby incorporated by reference.
[0044] Although in the above discussed embodiment container 18 has
a flexible, bag-like configuration, in alternative embodiments it
is appreciated that container 18 can comprise any form of
collapsible container or semi-rigid container. Container 18 can
also be transparent or opaque and can have ultraviolet light
inhibitors incorporated therein.
[0045] It is appreciated that container 18 can be manufactured to
have virtually any desired size, shape, and configuration. For
example, container 18 can be formed having a compartment sized to
10 liters, 30 liters, 100 liters, 250 liters, 500 liters, 750
liters, 1,000 liters, 1,500 liters, 3,000 liters, 5,000 liters,
10,000 liters or other desired volumes and thus can be in a range
between any of the above volumes. Although container 18 can be any
shape, in one embodiment container 18 is specifically configured to
be complementary or substantially complementary to chamber 118 of
tank body 102, as discussed above.
[0046] In any embodiment, however, it is typically desirable that
when container 18 is received within the chamber 118, container 18
is at least generally uniformly supported by tank body 102. Having
at least general uniform support of container 18 by tank body 102
helps to preclude failure of container 18 by hydraulic forces
applied to container 18 when filled with fluid.
[0047] Depicted in FIG. 6 is a front side view of container
assembly 16 with container 18 in a folded or collapsed position. As
shown therein, container assembly 16 includes ports 230A and B
secured to upper end 22 of container 18. Ports 230A and B can be
secured by welding or other conventional techniques and include a
passageway extending therethrough that communicates with
compartment 28 (FIG. 5). Coupled with and extending from ports 230A
and B are fluid lines 232A and B, respectfully. Fluid lines 232A
and B are typically comprised of a flexible hose or tubing. Mounted
on the end of fluid line 232A and B are connectors 234A and B,
respectfully. Connectors 234A and B are designed for forming a
fluid coupling with an additional fluid line, container, or other
structure. In one embodiment, connectors 234A and B can comprise
aseptic connectors such as the KLEENPAK sterile connector available
from the Pall Corporation. Other sterile or non-sterile connectors
can also be used. An envelope 235 is removable positioned over each
connector 234A and B to help maintain sterility prior to use. A
tube clamp 238 can also be mounted on each fluid line 232A and B
for closing the fluid lines or controlling the flow of gas or
liquid therethrough. Fluid lines 232A and B are commonly used for
delivering liquids, gases or other components into or out of
container 18.
[0048] Also mounted at upper end 22 of container 18 is a port 240
having a gas line 242, typically in the form of a flexible hose or
tube, extending therefrom and having a gas filter 244 mounted on
the end thereof. Gas filter 244 typically has a barbed port 246
formed on the end thereof for removably receiving a gas line that
is coupled with a compressor or other gas source. As will be
discussed below in more detail, for proper positioning, expansion
and filling of container 18, it is helpful to initially partially
fill container 18 with a gas, such as air. The gas can be delivered
through port 246 on gas filter 244. Gas filter 244 filters the gas
so that no contaminates enter container 18. Once container assembly
16 is properly positioned within tank assembly 12, fluid and other
components can be delivered into container 18 through one of fluid
lines 232A or B while the displaced gas exits out through the other
fluid line 232A or B. A tube clamp 238 can also be positioned on
gas line 242 to selectively close off the passage therethrough.
[0049] Finally, also mounted at upper end 22 of container 18 is a
temperature port assembly 250. Turning to FIG. 8, temperature port
assembly 250 comprises a port 252 that is secured to container 18
and a probe adapter 254 that is coupled with port 252. Port 252 has
a conventional design that includes a barbed stem 256 having a
passage 258 extending therethrough and a flange 260 radially
outwardly projecting therefrom. Flange 260 is welded or otherwise
secured to container 18 so that passage 258 communicates with
compartment 28 (FIG. 5). Probe adapter 254 comprises a flexible
sleeve 264 having a first end 266 and an opposing second end 268.
Encircling and radially outwardly projecting from first end 266 is
a mounting flange 270. Likewise, encircling and radially outwardly
projecting from second end 268 is a support flange 272. A tubular
stem 274 projects in axial alignment with sleeve 264 from a side of
mounting flange 270 opposite of sleeve 264.
[0050] Probe adapter 254 also includes an elongated receiver 276
having a first end 278 and an opposing second end 280. As shown in
FIG. 9, receiver 276 includes an elongated body 281 that typically
has a substantially cylindrical configuration and extends between
first end 278 and second end 280. Body 281 has an interior surface
282 that bound a cavity 284. Body 281 is closed except for an
opening 286 formed at first end 278. A tubular catch 288 is mounted
on and projects from first end 278 of body 281 in alignment with
opening 286. A flange 289 encircles and radially outwardly projects
from body 281 at first end 286.
[0051] During assembly, second end 280 of body 281 is passed down
through stem 274, mounting flange 270, sleeve 264, and supporting
flange 272 so that second end 280 projects down below support
flange 272. Body is advanced until flange 289 rests against stem
274. In this configuration, a friction tight fit is formed between
body 281 and stem 274. However, during radiation sterilization of
container assembly 16, body 281 and stem 274 can weld together.
Otherwise, if desired, an adhesive or other conventional welding
techniques can be used to secure the structures together. In yet
other embodiments, probe adapter 254 can be formed as a single
unitary member or as other combinations of members secured
together.
[0052] As also shown in FIG. 9, a cavity 290 is also formed between
an interior surface 291 of sleeve 264 and the exterior surface of
receiver 276. During assembly, port 252 is slid into cavity 290,
the parts being sized so that a friction fit is formed
therebetween. A tie 292 can then be cinched around sleeve 264 so as
to ensure a liquid type seal between sleeve 264 and port 252.
[0053] In the assembled configuration, sleeve 264 is inserted
within retainer 204 (FIG. 2) of tank body 102 so that mounting
flange 270 rests on flange 208 of retainer 204. An annular gasket
294 having an opening 295 (FIG. 8) extending therethrough, is then
positioned on top of mounting flange 270. Finally, a clamp 296
(FIG. 8), such as a tri-clamp, is positioned around flange 208,
mounted flange 270 and gasket 294 so that when clamp 296 is closed
and tightened, these structures are securely held together. Port
252 and the portion of container 18 secured thereto are thus
secured to and supported by retainer 204. An elongated temperature
probe 210, commonly referred to as an RTD, can be advanced down
into cavity 284 of receiver 276. A collar 298 mounted on probe 210
can be threaded onto catch 288 so as to secure temperature probe
210 to receiver 276.
[0054] By inserting temperature probe 210 within receiver 276,
temperature probe 210 can measure the temperature of the fluid
within container 18 through the wall of receiver 276. Receiver 276
protects temperature probe 210 from directly contacting the fluid
within container 18. As such, there is no risk of temperature probe
210 contaminating the fluid and temperature probe 210 can be reused
without sterilization or other cleaning. Furthermore, temperature
probe 210 is rigidly held in position at a distance spaced apart
from sidewall 162. As such, temperatures probe 210 give a more
accurate reading of the temperature of the fluid than if it was
positioned adjacent to sidewall 162. Temperatures probe 210 is also
held at a constant location independent of whether fluid is being
added or removed from container 18.
[0055] Returning to FIG. 6, container assembly 16 also comprises a
port 308 mounted at lower 24 of container 18, a drain line 310
extending from port 308, and a tube connector 312, such as a
sterile connector, mounted at the end of drain line 310. A hose
clamp 238 is also mounted on drain line 310 for closing the passage
therethrough. Finally, a support plate 314 is shown encircling
drain line 310 adjacent to port 308. As shown in FIG. 3, drain
opening 116 is typically formed oversized so that it is easy to
reach up through drain opening 116 and grab drain line 310 or to
otherwise pass drain line 310 down through drain opening 116.
Support plate 314 is simply a plate that is configured to be
received within drain opening 116 after drain line 310 passes
therethrough so that container 18 can be supported thereon. Support
plate 314 can have a slot 316 extending therethrough and radially
extending in from the perimeter edge so that drain line 310 can be
removably slid into slot 316. Alternatively, support plate 314 can
simply have a central hole through which drain line 310 is passed
during the assembly of container assembly 16.
[0056] If desired, other ports can be mounted on container 18 for
use in coupling other probes to container 18. For example, other
ports can be used for coupling probes such as pH probes, dissolved
oxygen probes, and the like. Examples of ports and how various
probes and lines can be coupled thereto is disclosed in United
States Patent Publication No. 2006/0270036, published Nov. 30, 2006
and United States Patent Publication No. 2006/0240546, published
Oct. 26, 2006, which are incorporated herein by specific reference.
Ports can also be used for coupling container 18 to secondary
containers, to condenser systems, and to other desired
fittings.
[0057] Depicted in FIG. 7 is a back side view of container assembly
16 with container 18 in a folded or collapsed position. As shown
therein, container assembly 16 further comprises an impeller
assembly 40. As depicted in FIG. 10, impeller assembly 40 comprises
an elongated tubular connector 44 having a rotational assembly 48
mounted at one end and an impeller 64 mounted on the opposing end.
More specifically, tubular connector 44 has a first end 46 and an
opposing second end 48 with a passage 50 that extends therebetween.
In one embodiment, tubular connector 44 comprises a flexible tube
such as a polymeric tube. In other embodiments, tubular connector
44 can comprise a rigid tube or other tubular structures.
[0058] Rotational assembly 48 is mounted to first end 46 of tubular
connector 44. Rotational assembly 48 comprises an outer casing 50
having an outwardly projecting flange 52 and a tubular hub 54
rotatably disposed within outer casing 50. A bearing assembly can
be disposed between outer casing 50 and tubular hub 54 to permit
free and easy rotation of hub 54 relative to casing 50. Likewise,
one or more seals can be formed between outer casing 50 and tubular
hub 54 so that during use an aseptic seal can be maintained between
outer casing 50 and tubular hub 54 as tubular hub 54 rotates
relative to outer casing 50.
[0059] Hub 54 has an interior surface 56 that bounds an opening 58
extending therethrough. As will be discussed below in greater
detail, an engaging portion of interior surface 56 has a polygonal
or other non-circular transverse cross section so that a driver
portion of drive shaft 362 passing through opening 58 can engage
the engaging portion and facilitate rotation of hub 54 by rotation
of drive shaft 362. Hub 54 can also comprise a tubular stem 60
projecting away from outer casing 50. Hub 54 can couple with first
end 44 of tubular connector 42 by stem 60 being received within
first end 44. A pull tie, clamp, crimp or other fastener can then
be used to further secure stem 60 to tubular connect 42 so that a
liquid tight seal is formed therebetween. Other conventional
connecting techniques can also be used.
[0060] Impeller 64 comprises a central hub 66 having a plurality of
fins 68 radially outwardly projecting therefrom. It is appreciated
that a variety of different numbers and W8 configurations of fins
68 can be mounted on hub 66. Hub 66 has a first end 70 with a blind
socket 72 formed thereat. Socket 72 typically has a non-circular
transverse cross section, such as polygonal, so that it can engage
a driver portion of drive shaft 362. Accordingly, as will be
discussed below in greater detail, when a driver portion is
received within socket 72, the driver portion engages with impeller
64 such that rotation of drive shaft 362 facilities rotation of
impeller 64.
[0061] In one embodiment, hub 66 and fins 68 of impeller 64 are
molded from a polymeric material. In alternative embodiments, hub
and fins 68 can be made of metal, composite, or a variety of other
materials. If desired, an annular insert can be positioned within
socket 72 to help reinforce hub 66. For example, the insert can be
comprised of metal or other material having a strength property
greater than the material from which hub 66 is comprised.
[0062] Impeller 64 can be attached to connector 42 by inserting
first end 70 of hub 66 within connector 42 at second end 46. A pull
tie, clamp, crimp, or other type of fastener can then be cinched
around second end 46 of connector 42 so as to form a liquid tight
sealed engagement between impeller 64 and connector 42.
[0063] Returning to FIG. 7, rotational assembly 48 is secured to
container 18 so that tubular connector 42 and impeller 64 extend
into or are disposed within compartment 28 of container 18 (FIG.
5). Specifically, in the depicted embodiment container 18 has an
opening 74 at upper end 22. Flange 52 of outer casing 50 is sealed
around the perimeter edge bounding opening 74 so that hub 54 is
aligned with opening 74. Tubular connector 42 having impeller 64
mounted on the end thereof projects from hub 54 into compartment 28
of container 18. In this configuration, outer casing 50 is fixed to
container 18 but hub 54, and thus also tubular connector 42 and
impeller 64, can freely rotate relative to outer casing 50 and
container 18. As a result of rotational assembly 48 sealing opening
74, compartment 28 is sealed closed so that it can be used in
processing sterile fluids.
[0064] As depicted in FIG. 10, impeller assembly 40 is used in
conjunction with drive shaft 362. In general drive shaft 362
comprises a head section 364 and a shaft section 366 that can be
coupled together by threaded connection or other techniques.
Alternatively, draft shaft 362 can be formed as a single piece
member or from a plurality of attachable sections. Drive shaft 362
has a first end 368 and an opposing second end 370. Formed at first
end 368 is a frustoconical engaging portion 372 that terminates at
a circular plate 374. Notches 376 are formed on the perimeter edge
of circular plate 374 and are used for engaging drive shaft 362
with drive motor assembly 132 as will be discussed below.
[0065] Formed at second end 370 of drive shaft 362 is a driver
portion 378. Driver portion 378 has a non-circular transverse cross
section so that it can facilitate locking engagement within hub 66
of impeller 64. In the embodiment depicted, driver portion 378 has
a polygonal transverse cross section. However, other non-circular
shapes can also be used. A driver portion 380 is also formed along
drive shaft 362 toward first end 368. Driver portion 380 also has a
non-circular transverse cross section and is positioned so that it
can facilitate locking engagement within the interior surface of
hub 54 of rotational assembly 48.
[0066] During use, as will be discussed below in further detail,
drive shaft 362 is advanced down through hub 54 of rotational
assembly 48, through tubular connector 42 and into hub 66 of
impeller 64. As a result of the interlocking engagement of driver
portions 378 and 380 with hubs 66 and 54, respectively, rotation of
drive shaft 362 by a drive motor assembly facilitates rotation of
hub 54, tubular connector 42 and impeller 64 relative to outer
casing 50 of rotational assembly 48. As a result of the rotation of
impeller 64, fluid within container 18 is mixed.
[0067] It is appreciated that impeller assembly 40, drive shaft 362
and the discrete components thereof can have a variety of different
configuration and can be made of a variety of different materials.
Alternative embodiments of and further disclosure with respect to
impeller assembly 40, drive shaft 362, and the components thereof
are disclosed in United States Patent Publication No. 2011/0188928,
published Aug. 4, 2011 which is incorporated herein in its entirety
by specific reference.
[0068] As previously discussed with regard to FIG. 1, tank assembly
12 comprises drive motor assembly 132 mounted to sidewall 106.
Drive motor assembly 132 is used in conjunction with drive shaft
362 (FIG. 10) and can be used for mixing and/or suspending a
culture, solution, or other fluids within container 18 (FIG. 2).
Turning to FIG. 11, drive motor assembly 132 comprises a housing
304 having a top surface 306 and an opposing bottom surface 308. An
opening 310 extends through housing 304 from top surface 306 to
bottom surface 308. A tubular motor mount 312 is rotatably secured
within opening 310 of housing 304. Upstanding from motor mount 312
is a locking pin 316. A drive motor 314 is mounted to housing 304
and engages with motor mount 312 so as to facilitate select
rotation of motor mount 312 relative to housing 304. Drive shaft
362 is configured to pass through motor mount 312 so that engaging
portion 372 of drive shaft 362 is retained within motor mount 312
and locking pin 316 of motor mount 312 is received within notch 376
of drive shaft 362. As a result, rotation of motor mount 312 by
drive motor 314 facilitates rotation of drive shaft 362. Further
discussion of drive motor assembly 132 and how it engages with
drive shaft 362 and alternative designs of drive motor assembly 132
are provided in United States Patent Publication No. 2011/0188928
which was previously incorporated herein by specific reference.
[0069] To facilitate operation, rotational assembly 48 is coupled
with drive motor assembly 132. Specifically, as depicted in FIG.
12, housing 304 of drive motor assembly 132 has an open access 384
that is recessed on a front face 386 so as to communicate with
opening 310 extending through housing 304. Access 384 is in part
bounded by a substantially C-shaped first side wall 388 that
extends up from bottom surface 308, a concentrically disposed
substantially C-shaped second side wall 390 disposed above first
side wall 388 and having a diameter larger than first side wall
388, and a substantially C-shaped shoulder 392 extending between
side walls 388 and 390. As shown in FIG. 5, a door 394 is hingedly
mounted to housing 304 and selectively closes the opening to access
384 from front face 386. Returning to FIG. 12, door 394 is secured
in a closed position by a latch 396. Positioned on first side wall
388 is a section 398 of a resilient and/or elastomeric material
such as silicone. Other sections 398 of similar materials can also
be positioned on first side wall 388 or the interior surface of
door 394.
[0070] As depicted in FIG. 13, to facilitate attachment of
rotational assembly 48 to housing 304, with door 394 rotated to an
open position, rotational assembly 48 is horizontally slid into
access 384 from front face 386 of housing 304 so that a support
flange 400 radially outwardly extending from an upper end of
rotational assembly 48 rests on shoulder 392 of access 384.
Rotational assembly 48 is advanced into access 384 so that the
passage extending through hub 54 of rotational assembly 48 aligns
with the passage extending through motor mount 312 (FIG. 11). In
this position, door 394 (FIG. 5) is moved to the closed position
and secured in the closed position by latch 396. As door 394 is
closed, casing 50 of rotational assembly 48 is biased against the
one or more sections 398 (FIG. 12) of resilient material so as to
clamp rotational assembly 48 within access 384 and thereby prevent
unwanted rotational movement of casing 50 relative to housing 304
of drive motor assembly 132.
[0071] Once rotational assembly 48 is secured to drive motor
assembly 132, drive shaft 362 (FIG. 10) can be advanced down
through drive motor assembly 132 and into impeller assembly 40 so
as to engage impeller 64. Once drive shaft 362 is properly
positioned, drive motor assembly 132 can activated causing drive
shaft 362 to rotate impeller 64 and thereby mix or suspend the
fluid within container 18.
[0072] On embodiment of the present invention includes means for
mixing the fluid within container 18. One example of such means
comprises impeller assembly 40, draft shaft 362 and drive motor
assembly 132. In alternative embodiments of the means for mixing,
impeller assembly 40 can be replaced with a drive shaft that
extends through a dynamic seal on container 18 and has an impeller
mounted on the end thereof within container 18. In yet other
embodiments, the means for mixing can comprise a stir bar, impeller
or other form of mixer disposed within container 18 and a magnetic
mixer disposed outside of container 18 that can rotate the mixer
within container 18 through the use of a magnetic force. Other
conventional mixers can also be used.
[0073] One typical example of how the inventive fluid heating
system 10 can be used will now be provided. Initially, container
assembly 16 is fabricated at a plant so that it is collapsed and
sterilized as a complete assembly. Either just prior to or after
placement of container assembly 16 within compartment 28 of tank
assembly 12, container assembly 16 is partially filled with a gas
through gas filter 244 (FIG. 6). By so doing, container assembly 16
expands enabling it to be easily positioned within and coupled to
tank assembly 12. Specifically, as shown in FIG. 5, drain line 310
is passed out through drain opening 116 in floor 114 and support
plate 314 is fitted within drain opening 116; temperature port
assembly 215 is coupled with retainer 204 of tank assembly 12 and
rotational assembly 48 of container assembly 16 is coupled with
drive motor assembly 132 of tank assembly 12 each has previously
discussed. At different stages, more gas can be injected into
container assembly 16 to ensure proper placement and coupling of
container assembly 16 and to avoid any potential risk of kinking
container 18 as it is filled with liquid.
[0074] Once container assembly 16 is properly positioned, fluid
line 232A is coupled with a fluid source while fluid line 232B is
coupled with a gas outlet line. These couplings are made
aseptically so as to ensure no breach and sterility. The desired
fluid is then dispensed into container 18 through fluid line 232A
while the displace gas is passed out through fluid line 232B. As
desired, the fluid and components thereof can be delivered in
different stages. For example, container assembly 16 can initially
be substantially filled with media followed by delivering a culture
of cells or microorganisms. During this fluid filling and gas
evacuation process, fluid lines 232A and 232B can pass out of tank
assembly 12 through slots 124A and B on lip 120. This ensures that
if lid 104 is closed, that the fluid lines are not damaged. At some
stage, temperature probe 210 is secured within probe adaptor 254 as
discussed above. The electrical wires extending from temperature
probe 210 can likewise pass out through a slot 320 formed on lip
120 of tank assembly 12 as shown in FIG. 1, so as to avoid any
damage thereto when lid 104 is closed.
[0075] With rotational assembly 48 secured to drive motor assembly
132, drive shaft 362 is passed down through drive motor assembly
132 and into impeller assembly 40 where it couples with impeller
64. Once all of the attachments and couplings are complete and
container 18 is filled with the desired fluid, clamps 238 are
closed on fluid lines 232A and 232B (FIG. 6) so as to close off any
further communications through the lines. Fluid lines 232A and 232B
can then be disconnected from the fluid source and the gas outlet
line after which the entire fluid lines 232A and 232B can be coiled
and placed on top of container 18 within tank assembly 12. Lid 104
is then closed and locked in place using fastener 156.
[0076] Either before or after closing lid 104, drive motor assembly
132 is activated to begin mixing fluid within container assembly
16. This mixing of the fluid is not always required by helps to
ensure that all of the fluid is uniformly heated within container
18. Furthermore, the mixing helps to ensure that the fluid is
homogeneous when it is dispensed for subsequent use. Heated fluid
is pumped through the jacket of tank assembly 12 so that fluid
within container 18 is heated. The heating can be started at any
stage, i.e., before or after disconnecting fluid line 232A from the
fluid source. By having lid 104 closed and all sides of tank
assembly 12 heated, along with the fluid in container 18 being
mixed, the fluid can be uniformly and accurately heated with
precision. The fluid is typically heated to a desired temperature
after which that temperature is maintained for desired period of
time to achieve desired results.
[0077] For example, to inactivate yeast, the fluid within container
18 is heated to a temperature of approximately 60.degree. and
maintained at that temperature for approximately 75 minutes. The
temperature and the time for maintaining the temperature can vary
depending on the desired processing. Furthermore, the temperature
may be raised or lowered at different stages. Likewise, in contrast
to using tank assembly 12 for heating, it is also appreciated that
chilled fluid can be passed through the jacket of tank assembly 12
for chilling the fluid within container assembly 16.
[0078] To ensure that all of the fluid in container assembly 16 is
properly heated, an electrical heating element 322, as shown in
FIG. 5, can be wrapped around the portion of drain line 310
extending between contain 18 and clamp 238. Electrical heating
element 322 can heat the fluid within drain line 310 to the same
temperature as the fluid within container 18. This ensure proper
heating of the fluid within drain line 310. Clamp 238 is not opened
until after all of the fluid has been properly heated.
[0079] Once the fluid within container assembly 16 has been
properly processed, the heating can be discontinued. Drain line 310
can then be coupled in a sterile manner with a container or further
line for draining fluid from container 18. If desired, mixing of
the fluid within container 18 may continue to ensure that the fluid
is homogeneous as it is dispensed.
[0080] When the processing is complete, drive shaft 362 is removed
and rotational assembly 48 is separated from drive motor assembly
132. Container assembly 16 can then be separated from tank assembly
12 and disposed of A second container assembly 16 can then be
couple with tank assembly 12 in the same manner as discussed above
and the process repeated.
[0081] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *